Cell Therapy in Diabetic Patients With ST-Segment Elevati... | NCT01307371

Studies
Cell Therapy in Diabetic Patients With ST-Segment Elevation Myocardial Infarction(STEMI)

NCT01307371

Sponsor

Xijing Hospital

Status

Unknown status

Last Update Posted

Mar 2, 2011Estimated

Enrollment

110Estimated

Phase

Not provided

Conditions

Left Ventricular Function Systolic Dysfunction
Left Ventricular Function Diastolic Dysfunction
Death
Myocardial Reperfusion Injury

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2007

Primary Completion Date

Mar 2008Actual

Completion Date

Dec 2011Estimated

First Submitted Date

Feb 24, 2011

First Submission Date that Met QC Criteria

Feb 28, 2011

First Posted Date

Mar 2, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2011

Last Update Posted Date

Mar 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone percutaneous coronary intervention (PCI).

Detailed Description

Stem cells are capable of the important properties of self-renewal and differentiation plasticity. Human autologous bone marrow mononuclear cells (BMMNC) contain CD34+ haematopoietic and CD34- mesenchymal stem cells. Both of these cell types may contribute to heart muscle repair in acute myocardial infarction (AMI). In recent years, a variety of clinical trials have explored the hypothesis that BMMNC transplantation may enhance the recovery of left ventricular function after AMI. The use of BMMNC is clinically justified and ethically unquestionable because no severe side effects have been reported and immunosuppressive therapy is unnecessary. More over, our previous work showed that patients without diabetes may benefit more from BMMNC transplantation. Thus, the aim of the present study was to investigate the efficacy and mechanism of bone marrow mononuclear cells (BMMNC) transplantation for diabetic and non-diabetic patients with ST-segment elevation myocardial infarction (STEMI)who have undergone PCI.

Conditions Module

Conditions

Left Ventricular Function Systolic Dysfunction
Left Ventricular Function Diastolic Dysfunction
Death
Myocardial Reperfusion Injury

Keywords

Bone Marrow Mononuclear cells;
Diabetes;
ST-segment Elevation Myocardial Infarction;
Percutaneous Coronary Intervention;
Left Ventricular Function

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

110Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Diabetes		Patients with diabetes.
non-diabetes		Patients without diabetes.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of patient death during the follow up period	Number of patient death during the follow up period as a measure of safety	4years

Secondary Outcomes

Measure	Description	Time Frame
Left ventricular ejection fraction	Left ventricular ejection fraction as evaluated by echocardiography and SPECT	4 years
Myocardial perfusion scores as evaluated by Single-photon emission computed tomography (SPECT)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age between 25 and 60 years old
STEMI according to the WHO definition
PCI <12 hours from the onset of symptoms
LAD disease with an open infarct related artery

Exclusion Criteria:

previous myocardial infarction (MI)
cardiomyopathy
atrial fibrillation or flutter
previous heart surgery
severe valvular heart disease
disease of the hematopoietic system
NYHA functional class IV heart failure at baseline
severe renal, lung and liver disease
cancer
intra-cardiac thrombus
bone marrow disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

25 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Patients of STEMI with the culprit lesion of left anterior decending (LAD)coronary artery were enrolled in this study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Feng Cao, MD, PhD	Air Force Military Medical University, China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Xijing Hospital	Recruiting	Xi'an	Shaanxi	710032	China

Condition Browse Module

MeSH Terms

ID	Term
D003643	Death
D015428	Myocardial Reperfusion Injury
D003920	Diabetes Mellitus
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D009202	Cardiomyopathies
D006331	Heart Diseases

Browse Leaves

Not provided

Browse Branches

Not provided